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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02448589 |
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Date of registration:
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11/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Investigation of TAS-119 Monotherapy
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Scientific title:
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A Phase I, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of TAS-119 in Patients With Advanced Solid Tumors |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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74 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02448589 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Italy
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Netherlands
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Spain
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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Inclusion criteria include the following:
1. Is a male or female, = 18 years of age, who has provided written informed consent.
2. Has histologically or cytologically confirmed advanced, unresectable, metastatic solid
tumor(s) for which the patients have no available therapy likely to provide clinical
benefit.
3. Must have an archival FFPE tumor sample available, to be provided to the Sponsor upon
request.
4. In the Expansion Phase: patients should be willing to undergo tumor core biopsy
procedure at pre-treatment and on Day 4, Cycle 1 if, in the judgment of the
investigator, it is considered clinically safe and appropriate to do so. This
requirement is optional but preferred for patients in Dose Escalation.
5. Has adequate organ function.
Women of childbearing potential must have a negative pregnancy test (urine or serum) within
7 days prior to starting the study drug. Both males and females and must agree to use
effective birth control during the study if conception is possible during this interval.
Exclusion:
1. Has received prior treatment with TAS-119.
2. Has received treatment with any proscribed treatments within specified time frames
prior to study drug administration.
3. Has a serious illness or medical condition(s).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Advanced Solid Tumors
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Intervention(s)
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Drug: TAS-119
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Primary Outcome(s)
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
[Time Frame: Up to 2.5 Years]
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Secondary ID(s)
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2014-001272-63
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TAS-119-102
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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